Application of Mitoxantrone Hydrochloride Injection in Transoral Robotic Thyroid Cancer Surgery

NCT07354698 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: No.08[2024]
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Dear Patient, You are invited to participate in a clinical study investigating the Application of Mitoxantrone Hydrochloride Injection for Lymphatic Tracing in Transoral Robotic Thyroid Cancer Surgery. This protocol (Protocol No.: \[To be filled\]) has been reviewed and approved by the Ethics Committee of the Army Center of Specialized Medicine. I. Background and Objectives 1.1 Disease Burden and Current Treatments 1.1.1 Thyroid Cancer Surgery Thyroid cancer, the most common head and neck malignancy, exhibits rising global incidence. Central compartment lymph nodes are frequent sites of metastasis in papillary thyroid carcinoma (PTC). Transoral endoscopic thyroid surgery offers superior cosmesis versus open surgery. The da Vinci® robotic system enhances visualization and instrument maneuverability, overcoming technical limitations of narrow endoscopic operating channels. 1.1.2 Lymphatic Tracers in Thyroid Surgery Mitoxantrone Hydrochloride Injection for Lymphatic Tracing is China's only approved tracer for thyroid lymphatic mapping. Its high lymphotropic specificity enables: Lymph node mapping: Forms nanocrystals that permeate lymphatics, staining nodes blue. Parathyroid negative imaging: Spares parathyroid glands, aiding their identification and reducing postoperative hypocalcemia. 1.2 Study Objectives Primary: Compare lymph node dissection efficacy and parathyroid protection between: Intervention: Transoral robotic thyroid lobectomy/total thyroidectomy + central neck dissection (CND) with lymphatic tracing. Control: Identical surgery without tracing. Secondary:

1. 1.Compare postoperative parathyroid function between groups.
2. 2.Evaluate tracer sensitivity for metastatic lymph nodes.

Conditions

Papillary Thyroid Cancer

Keywords

Mitoxantrone Hydrochloride Injection; Transoral Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Number of parathyroid missections

  Number of parathyroid missections

  1week

Secondary Outcomes (1)

• Number of lymph node dissections in the central region

  2week

Study Arms (2)

Mitoxantrone Hydrochloride Injection

EXPERIMENTAL

The experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation.

Drug: mitoxantrone hydrochloride injection

the blank control group

NO INTERVENTION

the blank control group does not receive any tracers, and the operating surgeon distinguishes the parathyroid glands and lymph nodes with the naked eye with experience, anatomy, etc.

Interventions

mitoxantrone hydrochloride injection DRUG

The experimental group used mitoxantrone hydrochloride injection as a lymphatic tracer to distinguish the parathyroid glands and lymph nodes according to the blue staining during the operation.

Mitoxantrone Hydrochloride Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old, both male and female;
• Preoperative neck ultrasound and/or puncture pathology suggested thyroid cancer, and postoperative pathology diagnosed thyroid cancer (tumor diameter \<4cm);
• There are no obvious contraindications to surgery during routine preoperative examination;
• Meet the indications for thyroid lobe/total resection + unilateral/bilateral central lymph node dissection;

You may not qualify if:

• Those who have a history of severe drug allergy or are allergic to the drugs in this study;
• Those with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney, and hematological system;
• Combined with parathyroid disease or other calcium and phosphorus metabolism-related diseases;
• Benign thyroid lesions;
• Received mitoxantrone treatment within 4 weeks;
• Enrolled in other clinical studies at the same time;
• Known history of psychotropic drug abuse, alcohol abuse or drug abuse;
• Pregnant or lactating women;
• According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study midway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory examination values, family or social factors, which may affect the safety of the subject or the collection of trial data.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital

Chongqicun, 400042, China

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Mitoxantrone

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds

Central Study Contacts

Yan Xu, PhD

CONTACT

15923100038; xy931@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)